CDC Zika Virus Specimens for Research & Development and Diagnostic Technologies

CDC Zika Virus Specimens for Research & Development and Diagnostic Technologies

The Centers for Disease Control and Prevention (CDC) has transferred Zika virus specimens and CDC-developed diagnostics since CDC became involved to support the public health response for the Zika virus outbreak in February 2016. Such efforts continue today.

To date, CDC has shipped relevant Zika specimens for more than three years to 18 countries and 33 US states and territories, and continues to conduct transfers. The different strains/isolates of the Zika virus are essential to further Zika research, increase knowledge about the virus, and support vaccine and diagnostic test development.

CDC was the first organization to develop and receive the Food and Drug Administration (FDA) Emergency Use Authorizations (EUAs) for the Zika MAC-ELISA and real-time Trioplex RT-PCR (reverse transcriptase polymerase chain reaction) assays, two important Zika virus diagnostic tests. These diagnostic assays were, at first, the only tools for clinical testing of people exposed to Zika virus, symptomatic or not. The tests are still in use with modifications. The Zika MAC-ELISA was approved by the FDA on February 26, 2016. CDC developed a second Zika MAC-ELISA version using virus-like particle (VLP) technology, and received EUA approval on June 29, 2016. CDC made additional Zika MAC-ELISA modifications, receiving EUA approval in April 2018. CDC also developed Trioplex to detect and differentiate Zika, dengue, and chikungunya virus in samples which received EUA approval on March 17, 2016. CDC has shared these technologies, at no cost to partners initially, to improve the detection of Zika virus.

CDC scientists and staff have worked tirelessly to facilitate research and development of Zika, design and commercialize related diagnostic assays, and protect America’s health and quality of life. CDC is using both patented and non-patented technologies to support the Zika response. Working rapidly to develop an unprecedented Zika detection test in the Zika MAC-ELISA assay, CDC has distributed it to more than 60 public health laboratories and added commercial partners. CDC executed licenses with four major reference laboratories for the Zika MAC-ELISA assay for diagnostic development and clinical testing for Zika infections in patients. CDC has also licensed the Zika MAC-ELISA assay with new VLP technology to a company for mass production/diagnostic development and commercialization.